Class D — High Risk Devices
Class D represents the highest risk category in Indonesia's classification system. These are typically active implantables, life-sustaining devices, or devices with significant potential consequences from failure. They face the most intensive regulatory scrutiny.
Examples of Class D Devices
- Active implantable cardiac devices (pacemakers, implantable cardioverter-defibrillators)
- Cardiac stents (drug-eluting and bare metal)
- Cochlear implants
- Deep brain stimulators
- Spinal cord stimulators
- Total artificial hearts
- Devices for extracorporeal circulation
- Long-term implantable devices in direct contact with blood or central nervous system
Registration Pathway
Class D requires a comprehensive registration dossier with the highest level of clinical and technical documentation:
- Complete ASEAN CSDT dossier
- Full clinical data including clinical investigation reports where literature alone is insufficient
- Comprehensive risk management file (ISO 14971)
- Detailed traceability and recall plan (mandatory)
- Post-market surveillance plan
- Periodic Safety Update Reports (PSUR) commitment
- ISO 13485 mandatory
- Review timeline: 6–12 months minimum; complex devices may exceed this
Documentation Requirements
| Document | Class D Specific |
|---|---|
| Clinical Evaluation Report | Full, peer-reviewed clinical data; clinical investigation data where required |
| Risk Management File | Comprehensive per ISO 14971; residual risk justification mandatory |
| Traceability System | Mandatory — must be able to identify and locate all distributed units |
| Recall Plan | Formal documented plan required |
| PSUR commitment | Periodic safety reporting as directed by Kemenkes |
| Post-Market Surveillance Plan | Full PMS plan required at time of submission |
Post-Approval Obligations
Class D manufacturers face the most stringent ongoing obligations:
- Prompt adverse event reporting to Kemenkes (serious incidents — report as soon as possible, typically within 30 days or sooner for death/serious injury)
- Periodic safety update reports
- Field safety corrective action (FSCA) protocols must be established prior to launch
- Regular CDAKB inspections of the LAR are more frequent for Class D product holders
Halal Labeling Deadline
Class D devices (and biological products) have a Halal labeling compliance deadline of approximately 2039 under Government Regulation 42/2024, reflecting the complexity of material sourcing for these device categories.